The purpose of this study is to determine the effectiveness of the HITSystem in maximizing early infant diagnosis (EID) service utilization for HIV-exposed infants and early antiretroviral therapy (ART) initiation for infants diagnosed with HIV.

The investigators will compare differences in 8 critical intervention benchmarks for optimal EID diagnosis of HIV between control hospitals and hospitals using HITSystem. For each of the 8 EID intervention points, measures include whether it was completed at all (1-point) or never completed (0 points) and whether it was completed on-time (1 point) or off-time (0 points) for a maximum score of 16 and a minimum score of 0.

Initiation of OI prophylaxis at 6 weeks.

Collect dried blood spot (DBS) for PCR test by 6 weeks.

Receipt of DBS at lab within 10 days of collection.

Return of PCR results from lab within 2 weeks.

Notify mother within 2 weeks of the EID provider receiving results.

Initiate all HIV-infected infants on ART within 4 weeks of notifying the mother.

Online, automated program designed to overcome current EID barriers by providing efficient prospective tracking of HIV-exposed infants and triggering electronic action "alerts" for both EID providers and lab technicians when time sensitive interventions are overdue for specific infants.

Other Name: HIV Infant Tracking System

Active Comparator: Control Hospitals

Existing standard of EID care

Other: Standard of Care

current procedures that follow Kenyan National EID guidelines to diagnose and manage HIV infection among HIV-exposed infants.

Detailed Description:

The current EID system is hampered by significant structural barriers that contribute to late and sporadic testing of HIV-exposed infants, lost or delayed test results from the laboratory, and the absence of a reliable system to notify mothers of test results or the need to return to the hospital.11-12 Consequently, in Kenya only about one-third of HIV-exposed infants receive complete EID care through 18 months of age, and less than 20% of diagnosed HIV+ infants are initiated on life saving ART. 13

Our pilot data from two hospitals in Kenya (one urban, one peri-urban) demonstrate the acceptability and feasibility of implementing this intervention. Using a pre-post intervention design the investigators compared EID outcomes from n=330 mother-infant pairs assessed by retrospective chart review during the 12 months prior to the initiation of the intervention to n=460 mother-infant pairs enrolled in the HITSystem intervention over the course of several months (9 and 6 months, respectively). Pilot data indicate a 3 fold increase in EID retention (31% vs. 97%, p<0.001), and more than doubled infant ART initiation rates (44% vs. 95%, p<0.001).14 These data have resulted in great interest and support from the Kenya Ministry of Health for this study, the findings of which will influence national EID dissemination decisions.

To more rigorously evaluate the impact of the HITSystem intervention on EID care in a low-resource country and implications for the feasibility of scaling up this intervention, the investigators will use a cluster randomized control trial among 6 Kenyan government hospitals (3 intervention and 3 standard of care; matched). Three specific aims guide the proposed study:

Aim 1. Conduct a randomized controlled trial to evaluate the efficacy of the HITSystem in improving the timely provision of 8 critical intervention benchmarks for optimal Early Infant Diagnosis of HIV and management.

Aim 2. To identify among HIV-exposed infants predictors of (1) incomplete EID care and (2) time periods most vulnerable to loss of contact at both intervention and control sites.

Aim 3. To estimate the incremental cost-effectiveness of the HITSystem in improving complete EID care across study arms, and to assess user satisfaction among key stakeholders.

This study will scientifically evaluate the public health impact of the HITSystem to improve critical EID outcomes in low-resource settings. Cost-effectiveness analyses will inform the feasibility of scaling up the HITSystem in other settings, and opportunities to adapt the technology to address other health outcomes.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

HIV+ mother whose infant is <18 months of age

Ability to provide consent

Exclusion Criteria:

-

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02072603